Haemonetics Corporation, a global medical technology leader, has announced that the US FDA has approved expanded labeling for its VASCADE MVP XL venous vascular closure system. 

 

The approval now covers procedures using 10-14F inner diameter and up to 17F outer diameter procedural sheaths, including market-leading technologies for pulsed field ablation (PFA) and left atrial appendage closure (LAAC) to treat atrial fibrillation.

 

The FDA’s decision was supported by results from the AMBULATE EXPAND trial, a multicenter, prospective, single-arm pivotal study evaluating the safety and effectiveness of closure for large 17F sheaths. 

 

Across 77 patients at eight US centers, the trial reported 0% major and 0% minor access site closure-related complications and a median time to ambulation of just 2.4 hours.

 

Previously cleared for 10-12F ID and 15F maximum OD sheaths, the VASCADE MVP XL system now stands as the only extravascular venous closure system clinically proven for electrophysiology procedures using up to 17F OD sheaths. This eliminates the need for physicians to downsize procedural sheaths, a step that can increase procedure time.

 

“VASCADE MVP XL has become the device of choice in advanced vascular closure, delivering differentiated clinical benefits and economic advantages for healthcare providers,” said Ken Crowley, Vice President and General Manager, Interventional Technologies at Haemonetics. 

 

“With label expansion approval for fast-growing PFA and LAAC technologies, we are poised to accelerate our commercial strategy and momentum, with opportunities to support a greater number and broader range of procedures at hospitals and ambulatory surgical centers across the U.S.”

 

Haemonetics’ VASCADE portfolio also includes the VASCADE system, for small-bore 5-7F femoral arterial and venous procedures, and the VASCADE MVP system, designed for mid-bore 6-12F multi-access femoral venous procedures. 

 

All systems feature collapsible disc technology and a proprietary resorbable collagen patch designed to promote rapid hemostasis, reduce complications, improve patient satisfaction, and enable same-day discharge.